Trial studying safety and effects for Ventricular Tachycardia
Official title Safety and Effectiveness of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere VT)
ClinicalTrials.gov ID: NCT07585968
What this study is testing
- What it's testing
- The study will evaluate whether this catheter and ablation system is safe and works to treat recurrent, sustained ventricular tachycardia caused by a prior heart attack.
- Who it's for
- Adults who have repeated, sustained monomorphic ventricular tachycardia that started after a previous heart attack.
- What's involved
- Participants will undergo a procedure using the Sphere‑9 catheter and Affera Ablation System to treat their heart rhythm, followed by clinic visits and tests to monitor safety and results.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 85
You may be able to join if
- Prior myocardial infarction (MI).
- At least one episode of sustained (continuous for \>30 seconds or requiring ICD intervention for termination) monomorphic ventricular tachycardia...
- Recurrence of sustained ventricular tachycardia despite Class I or III antiarrhythmic drug therapy or ICD intervention.
- Implanted with an implantable cardiac defibrillator (ICD) or CRT-D for at least 2 months prior to the ablation procedure.
- Age 18 through 85 years old.
You likely can't join if
- Incessant VT necessitating hemodynamic support prior to the ablation procedure.
- Unstable polymorphic VT or ventricular fibrillation (VF).
- Idiopathic VT or VT of non-ischemic cardiomyopathy.
- VT secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause (e.g., drug-induced arrhythmia).
- VT or VF thought to be from channelopathies.
- More than two prior VT ablations at any time, more than one prior VT ablation within 12 months prior to the ablation procedure, or any VT ablation...
See the full eligibility criteria
- Prior myocardial infarction (MI).
- At least one episode of sustained (continuous for \>30 seconds or requiring ICD intervention for termination) monomorphic ventricular tachycardia within the 6 months prior to enrollment.
- Recurrence of sustained ventricular tachycardia despite Class I or III antiarrhythmic drug therapy or ICD intervention.
- Implanted with an implantable cardiac defibrillator (ICD) or CRT-D for at least 2 months prior to the ablation procedure.
- Age 18 through 85 years old.
- Willing and able to provide informed consent.
- Willing and able to comply with all pre-, post-, and follow-up testing requirements.
- Incessant VT necessitating hemodynamic support prior to the ablation procedure.
- Unstable polymorphic VT or ventricular fibrillation (VF).
- Idiopathic VT or VT of non-ischemic cardiomyopathy.
- VT secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause (e.g., drug-induced arrhythmia).
- VT or VF thought to be from channelopathies.
- More than two prior VT ablations at any time, more than one prior VT ablation within 12 months prior to the ablation procedure, or any VT ablation within 4 weeks prior to the ablation procedure.
- Sarcoidosis.
- Hypertrophic cardiomyopathy, except when due to an apical aneurysm.
- Unstable angina.
- Active myocardial ischemia.
- Type 1 myocardial infarction within 2 months (60 days) prior to the ablation procedure.
- Any percutaneous coronary intervention performed in a setting of unstable angina or acute MI (STEMI or non-STEMI) within 2 months (60 days) prior to the ablation procedure.
- Any cardiac surgery within 2 months (60 days) prior to the ablation procedure. Note: ICD lead implant/replacement falls under this exclusion, but ICD generator-only replacement does not.
- Left ventricular ejection fraction (LVEF) \<15%.
- NYHA Class IV heart failure.
- Decompensated heart failure.
- Extravascular ICD (EV-ICD) or subcutaneous ICD (S-ICD)
- Currently receiving support, or anticipated to receive support prior to the index ablation procedure, via extracorporeal membrane oxygenation (ECMO).
- Circulatory/ventricular assist device (VAD; surgical or percutaneous) implanted, planned or required for the procedure.
- Severe aortic or mitral stenosis, or severe aortic or mitral regurgitation.
- Presence of prosthetic valve in the aortic or mitral valve.
- Patients with advanced COPD (on home oxygen).
- Presence of intracardiac tumor or other abnormality that precludes vascular access, catheter introduction, or manipulation.
- Thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the index ablation procedure or with neurologic deficit.
- Left atrium (LA) or left ventricle (LV) intracardiac thrombus on imaging.
- Severe bleeding, clotting or thrombotic disorder, or thrombocytopenia (defined as platelet count \<80,000).
- Contraindication to anticoagulation.
- End-stage renal disease (requiring dialysis).
- Acute illness, active infection, or sepsis.
- Life expectancy less than 12 months.
- Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence.
- Body mass index \>45 kg/m2.
- Known ongoing drug or alcohol dependency.
- Current or anticipated participation in any other ongoing study of a drug, device, or biologic during the duration of the study not pre-approved by the Sponsor.
- Vulnerable people (such as a prisoner, handicapped or mentally disabled person, or person under tutelage or guardianship).
- Any other condition that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would pose a significant hazard to the subject if an ablation procedure...
The study team makes the final eligibility decision.
Where it is enrolling
- Indianapolis, Indiana, United States
- Manhasset, New York, United States
- Winston-Salem, North Carolina, United States
- Columbus, Ohio, United States
- Austin, Texas, United States
Compensation & support
A stipend or payment for your time may be offered.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Indianapolis, Indiana, United States; Manhasset, New York, United States; Winston-Salem, North Carolina, United States; Columbus, Ohio, United States; Austin, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.